PRECAINE- topical anesthetic gel gel

Precaine by

Drug Labeling and Warnings

Precaine by is a Prescription medication manufactured, distributed, or labeled by Pascal Company, Inc., Alexia Petropoulos. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE FORMS & STRENGTHS

Contains: Lidocaine 8%, Dibucaine 0.8%

in a flavored aqueous base.

Net Contents 30g

DOSAGE & ADMINISTRATION

Application Directions:

• For topical use only
• For best results apply to previously dried oral mucosa with cotton swab or similar applicator for adequate control of pain.
• Removal of excess saliva during application minimizes dilution of the anesthetic and permits maximum penetration.
• Not more than one ounce (28g) per patient should be applied during a 24 hour period.

WARNINGS

Recommended dosage should not be exceeded due to possible side effects. Keep out of the reach of children. For professional use only. Do not use in the eyes. Avoid swallowing.

CONTRAINDICATIONS

Precaine is contraindicated in patients with known hypersensitivity to amine or quinoline type anesthetics.

OTHER SAFETY INFORMATION

For product MSDS information please go to www.pascaldental.com or contact Pascal directly.

PRINCIPAL DISPLAY PANEL

Precaine

Topical Anesthetic Gel for oral use

Strawberry

INGREDIENTS AND APPEARANCE

PRECAINE 
topical anesthetic gel gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10866-0062
Route of Administration	BUCCAL, TOPICAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	80 mg  in 1 g
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)	DIBUCAINE	8 mg  in 1 g

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10866-0062-1	30 g in 1 JAR; Type 0: Not a Combination Product	08/01/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/01/2000

Labeler - Pascal Company, Inc. (009260217)

Establishment
Name	Address	ID/FEI	Business Operations
Pascal Company, Inc.		009260217	manufacture(10866-0062)